Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
Bionova Medical Inc.
802-1025
In Commercial Distribution

  • 00850047730138 ()

  • Length: 10 Centimeter
  • Width: 25 Centimeter


  • Wound regenerating polysaccharide agent
No Description
Bionova Medical Inc.
802-1012
In Commercial Distribution

  • 00850047730121 ()

  • Length: 10 Centimeter
  • Width: 12.5 Centimeter


  • Wound regenerating polysaccharide agent
No Description
Bionova Medical Inc.
501-1020
In Commercial Distribution

  • 00850047730107 ()

  • Length: 10 Centimeter
  • Width: 20 Centimeter


  • Cavity-wound management dressing, non-antimicrobial
Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-surgiclose-silicone/
KERECIS hf.
10 x 18 cm fish skin
In Commercial Distribution

  • 05694310965170 ()
  • 05694310965163 ()

  • Height: 10 Centimeter
  • Width: 18 Centimeter
50214F56D0D

  • Animal-derived wound matrix dressing
Fish-skin graft for wound management. Kerecis® MariGen™ is indicated for the management of wounds including: Partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-marigen/
KERECIS hf.
7x10 cm
In Commercial Distribution

  • 05694310962445 ()
  • 05694310962438 ()

  • Length: 7 Centimeter
  • Width: 10 Centimeter
50200S03B0D

  • Animal-derived wound matrix dressing
Fish-skin graft for wound management. Kerecis® MariGen™ is indicated for the management of wounds including: Partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-marigen/
KERECIS hf.
Expanse 8x10 cm
In Commercial Distribution

  • 05694310962247 ()
  • 05694310962230 ()
  • 05694310962261 ()

  • Length: 8 Centimeter
  • Width: 10 Centimeter
50200N13B0D

  • Animal-derived wound matrix dressing
Fish-Skin Graft for Surgical Use. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgiclose/
KERECIS hf.
7x10 cm Meshed 2:1
In Commercial Distribution

  • 05694310961141 ()
  • 05694310961134 ()

  • Length: 7 Centimeter
  • Width: 10 Centimeter
50205N03D0D

  • Animal-derived wound matrix dressing
Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide® is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-graftguide/
KERECIS hf.
7x10 cm Meshed
In Commercial Distribution

  • 05694310961103 ()
  • 05694310961097 ()

  • Length: 7 Centimeter
  • Width: 10 Centimeter
50202N03D0D

  • Animal-derived wound matrix dressing
Fish-Skin Graft for Surgical Use. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgiclose/
KERECIS hf.
10x25 cm
Not in Commercial Distribution

  • 05694310960748 ()

  • Length: 10 Centimeter
  • Width: 25 Centimeter
50205S22D0D

  • Animal-derived wound matrix dressing
Fish-Skin Graft for Surgical Use. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgiclose/
KERECIS hf.
7x10 cm
In Commercial Distribution

  • 05694310960717 ()
  • 05694310960700 ()

  • Length: 7 Centimeter
  • Width: 10 Centimeter
50205S03D0D

  • Animal-derived wound matrix dressing
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